Lingual repositioning devices, controller station, and methods of treating and/or diagnosing medical disorders

ABSTRACT

Lingual repositioning devices have a mandibular piece having a teeth covering and a first housing proximate either a left molar portion or a right molar portion of the teeth covering. The first housing includes a stimulator protrusion extending therefrom at a position to extend toward a tongue of a user and to contact a lingual muscle of the tongue or includes a sensor portion extending therefrom at a position to extend toward a tongue of a user and to be positioned under the tongue. The stimulator protrusion encloses a stimulator and the first housing encloses a power source electrically connected to a circuit board and electrically connected to an electrode of a stimulator. A second housing at the other of the left or right molar portions has a stimulator protrusion or a sensor portion. The first and second housings may be removably attachable to the teeth covering.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/936,032, filed Nov. 15, 2019, the entirety of whichis incorporated herein by reference.

TECHNICAL FIELD

This application relates to lingual repositioning devices and methods oftreating and/or diagnosing obstructive sleep apnea and other sleepdisorders and/or medical conditions using the same, more particularly,to a lingual repositioning device that can provide electrical impulsestimulation to the muscle of the tongue for forward movement of thetongue.

BACKGROUND

Many individuals suffer from disordered breathing while asleep. Someexample disorders include obstructive sleep apnea (OSA), snoring, snorearousals, sleep-related hypoxia, and other conditions dependent on andcaused by snoring or OSA. OSA is a condition in which sleep isrepeatedly interrupted by an inability to breathe, which is typically aresults of intermittent obstruction of the airway by the tongue and ageneral relaxation of the muscles which stabilize the upper airwaysegment, which can cause a lack of oxygen, snoring, cardiovascular andneurological complications, such as sleep-induced hypertension, heartattacks, cardiac arrythmias, strokes, Alzheimer's disease, diabetes,weight gain, and depression.

Mandibular repositioning devices have been FDA-approved and used as atreatment for sleep apnea when treatment by a CPAP (Continuous PositiveAirway Pressure) machine has been ineffective for the particularpatient, or when a patient is unable to tolerate a PAP (Positive AirwayPressure) device. Most oral appliances on the market have only been ableto control approximately 50% of sleep apnea events. There are a largenumber of patients that are intolerant to PAP devices, some due to thePAP device or the mask but most due to excessive high air pressure thatmay be medically recommended for keeping an open airway. Repeatedadjustments have to be performed in attempts to make intolerant patientstolerate a PAP device, most of which require manual adjustments by aprofessional or require repeated sleep studies after a sleep study.Since a large number of patients with OSA have thus remained untreateddue to various reasons, there is a serious need for a new method oftreatment that can maintain an open airway during sleep using acombination of jaw stabilization and simultaneous advancement of the jawand tongue, i.e., a dynamic mandibular and lingual repositioning deviceas disclosed herein. There is also a need for such a device that cancontinuously learn (artificial intelligence) a particular personssleep-related breathing, blood pressure, heart rate and rhythm, bodypositioning, depth of sleep and oxygen levels, silent or symptomaticacid reflux during sleep and amount of bruxism (teeth grinding) overperiods of days, months and even years while the person sleeps at homeor elsewhere, thereby removing the need of performing expensive sleepstudies. While using such a device it should lend itself to continuouslymaking automatic, guided, algorithmic (SERVO) adjustments to thetreatment of these medical conditions and continuously providinginformation related to improvement in oxygen levels, breathing, bloodpressure, heart rate and rhythm, acid reflux and bruxism and sleepdepth, quantity and quality to the controller, cloud-based server systemand to the treating physician, providing a lifelong (life of the device)safe open airway with reliable normalization of oxygen, breathing andsleep.

SUMMARY

In all aspects, lingual repositioning devices are disclosed that have amandibular piece having a teeth covering having a left molar portionand/or a right molar portion and a first housing proximate at least oneof the left molar portion or the right molar portion. The first housingincludes a stimulator protrusion extending therefrom at a position toextend toward a tongue of a user and to contact a lingual muscle of thetongue. The stimulator protrusion encloses a stimulator, and the firsthousing encloses a power source electrically connected to an on-boardcircuit board and electrically connected to an electrode of thestimulator. The power source is a rechargeable battery and the firsthousing has a charging member in an exterior surface thereof that is inelectrical communication with the rechargeable battery. The on-boardcircuit board includes a receiver, a transmitter, and a microprocessorhaving instructions to activate the stimulator. The stimulatorprotrusion can enclose one or more sensors in communication with themicroprocessor of the on-board circuit board, which are selected fromthe group consisting of a pulse oxygen sensor, a vibration and airflowsensor, a pH sensor, a doppler ultrasound sensor, an M-Mode ultrasoundsensor, a 2D ultrasound sensor, 3D ultrasound sensor, a pressure platesensor for measuring bruxism, a pulse transit time sensor, non-invasiveventilation systolic/diastolic blood pressure sensor, a carotid doppler(trans-oral) sensor, and a cardiac trans-oral echocardiography sensor.

In all aspects, the on-board circuit board receives data from the one ormore sensors and activates the stimulator in the first housing as neededbased on the data to open an airway of a user.

In all aspects, a second housing proximate the other of the left molarportion or the right molar portion can be present have a stimulatorprotrusion extending therefrom at a position to extend toward a tongueof a user and to contact a lingual muscle of the tongue. The stimulatorprotrusion encloses a stimulator, and the second housing encloses apower source electrically connected to an on-board circuit board andelectrically connected to an electrode of the stimulator. The stimulatorprotrusion of the second housing can enclose a first sensor and/or asecond sensor in communication with the microprocessor of the on-boardcircuit board, which are selected from the group consisting of a pulseoxygen sensor, a vibration and airflow sensor, a pH sensor, a dopplerultrasound sensor, an M-Mode ultrasound sensor, a 2D ultrasound sensor,3D ultrasound sensor, a pressure plate sensor for measuring bruxism, apulse transit time sensor, non-invasive ventilation systolic/diastolicblood pressure sensor, a carotid doppler (trans-oral) sensor, or acardiac trans-oral echocardiography sensor.

In one embodiment, the first sensor and the second sensor of the secondhousing are different from one another and are different from the one ormore sensors of the first housing.

In all aspects, the on-board circuit board of the second housingincludes a receiver, a transmitter, and a microprocessor havinginstructions to activate the stimulator in the second housing. Theon-board circuit board of the second housing receives data from thefirst sensor and/or the second sensor and activates the stimulator inthe second housing as needed based on the data from the first sensorand/or the second sensor to open an airway of a user.

In one embodiment, the first housing and/or the second housing, ifpresent, is removable attachable to the teeth covering. The teethcovering can be a bite and mold disposable plastic teeth covering. Thefirst housing may be slidably received on the teeth covering or have asnap fit to the teeth covering.

In another aspect, mandibular lingual repositioning systems aredisclosed that include a mandibular lingual repositioning devicedescribed herein that include one or more sensors and a controllerstation in wireless communication with the mandibular lingualrepositioning device. The controller station has a circuit board whichincludes a microprocessor, a receiver, and a transmitter. Themicroprocessor has non-transitory memory having firmware and learningalgorithms stored therein. The receiver receives data from the one ormore sensors, while used by a user, and the microprocessor of thecontroller station processes the data and transmits stimulatoractivation instructions to the microprocessor of the on-board circuitboard.

In all aspects, the receiver and transmitter of the controller stationcommunicate with a database of a physician, the Internet, a personalelectronic communication device and combinations thereof. The controllerstation includes input and output ports for electrical interconnectionto a power source and/or other electronic devices, and has a firstcharging unit for the mandibular piece and a second charging unit forthe maxillary piece.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the disclosure can be better understood with referenceto the following drawings. The components in the drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present system.

FIG. 1 is a left-side view of a first embodiment of a mandibular lingualrepositioning device.

FIG. 2 is a side, perspective view of the mandibular piece of themandibular lingual repositioning device of FIG. 1.

FIG. 3 is a side, perspective view of the maxillary piece as itarticulates and fits with the mandibular lingual repositioning device ofFIG. 1.

FIG. 4 is a cross-sectional view of the mandibular lingual repositioningdevice along line 4-4 in FIG. 1.

FIG. 5 is front, perspective view of a controller station for use withthe devices disclosed herein.

FIG. 6 is an enlarged view of the left movement mechanism of themandibular lingual repositioning device of FIG. 1.

FIG. 7 is a an enlarged view of an alternate embodiment of the leftmovement mechanism of the mandibular lingual repositioning device.

FIG. 8 is an enlarged side view of an embodiment of a protrusive flange.

FIG. 9 is a side, perspective view of an embodiment of a mandibulardevice having at least a stimulator electrode therein.

FIG. 10 is an enlarged cross-sectional view of the mandibular devicealong line 9-9 in FIG. 9.

FIG. 11 is a cross-sectional view of another embodiment of a mandibulardevice that is removable attachable to a teeth covering.

FIG. 12 is a schematic illustration of a system in operativecommunication with the MRLD of FIG. 1 or the mandibular device of FIG.8.

DETAILED DESCRIPTION

The following detailed description will illustrate the generalprinciples of the invention, examples of which are additionallyillustrated in the accompanying drawings. In the drawings, likereference numbers indicate identical or functionally similar elements.

Referring now to FIGS. 1 to 4, a mandibular lingual repositioning device(MLRD) that is dynamic in its movement of the jaw(s) and tongue isrepresented collectively in FIG. 3 by reference number 100. The MLRD 100has a maxillary piece 102 seated on a mandibular piece 104 for operativecommunication of drivers built therein.

Turning to FIGS. 1 and 4, the mandibular piece 104 is shown, which has afirst teeth covering 106 and has a housing 108 proximate each of a leftmolar portion 110 and a right molar portion 112. A protrusive flange 114extends cranially from each housing 108, and a stimulator 116 extendsfrom each housing 108 toward the tongue at a position to lie under thetongue in contact with lingual muscles, in particular the Genioglossus(GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP).The stimulator protrusion 116 of each housing 108 should be fitted tothe user/custom made for the user to ensure proper contact with thelingual muscles. Each stimulator portion 116 while appearing somewhatboxy-looking in the drawings, is more preferably molded of moldablematerial suitable for use in a human oral cavity and has smoothtransitions to its shape and is shaped to match the shape of the user'smouth, especially to sit under the tongue in contact with the base ofthe tong and the floor of the mouth as shown in FIG. 4. The moldablematerial may be any of those commercially available or hereinafterdeveloped for use in a human oral cavity.

Referring now to the transverse cross-section of FIG. 4, each housing108 encloses, in a fluid-tight manner, a power source 120 electricallyconnected to a motor 122, to a circuit board 124, and to the stimulator116. A first driver 130 is operatively connected to each motor 122 forcranial to caudal adjustments of the device 100. The first driver 130 islinearly translatable by linkages 134 operatively connected to the motor122 within its housing 108 as shown in FIG. 3. The linkages 134 will befluid-proof, heat-resistant and acid-resistant and thus able towithstand the conditions found within the oral cavity of a user.

With reference to FIGS. 2 and 3, the maxillary piece 102 is shown, whichhas a second teeth covering 107 and has a housing 109 proximate each ofa left molar portion 111 and a right molar portion 113. Referring to thepartial cross-sectional view of FIG. 3, each housing 109 encloses apower source 121 electrically connected to a motor 123 and to a circuitboard 125. A second driver 132 is operatively connected to each motor123 for anterior to posterior adjustments of the device 100. The seconddriver 132 is linearly translatable by linkages 135 operativelyconnected to the motor 123 within its housing 109.

In all embodiments, the housings 108 and 109 may be fixedly attached tothe respective teeth covering, integral therewith, or removableattachable thereto. When removable attachable, the housings 108, 109 maybe slid over a molar portion of the teeth covering, have a snap fitthereto, an interference fit thereto, may be a two-piece compartmentthat snaps together over a predetermined location of the teeth covering,may be three-dimensionally printed to cover or fit over a portion of theteeth covering. In all embodiments, while the teeth coverings 106, 107are shown as full coverings for all teeth in the mandible and all teethin the maxilla, the teeth coverings are not limited thereto. Instead,each teeth covering may be a partial cover for one or more teeth, assuch, the mandibular piece 104 may be a two-part configuration having aleft and a right portion each with a housing 108 and the maxillary piece102 may be a two-part configuration having a left and a right portioneach with a housing 109.

In all embodiments herein, each housing 108, 109 is described herein aspositioned proximate a molar portion of a teeth covering, but is notlimited to any particular size, i.e., the number of teeth to which it isassociated. Each housing may be associated with one tooth region, atwo-tooth region, a three-tooth region, or whatever number of teeth isneeded to accommodate the size and position of the housing and itsstimulator protrusion.

Referring to FIGS. 1, 3, and 4, the protrusive flange 114 of themandibular piece 104 is an elongate flange that is releasably, removablyattached to or may be integral with the housing 108. A releasably,removably attachable protrusive flange 114 is shown in FIGS. 6 and 7 toaccommodate an interchangeability of protrusive flanges 114 of differentshapes and sizes to provide the best fit for the user's mouth. In theembodiment of FIG. 1, the protrusive flanges 114 are generally anelongate linear flange protruding cranially from each of the housing108.

Turning now to FIGS. 6 and 7, the protrusive flange 114′ is releasablyattachable to the housing 108 of the mandibular piece 104. Theprotrusive flange terminates with a post 144 opposite a free end 142thereof. The post 142 includes a releasably attachable feature 146, suchas a snap fit feature, a friction fit feature, or threaded holes asshown in FIG. 7. The housing 108 defines a receptacle 126 shaped toreceive the post 144. The receptacle 126 will have a releasablyattachable mating feature 128 that mates with the releasably attachablefeature 146 of the post 144. In FIG. 7, the releasably attachable matingfeature 128 is a set of threaded holes and screws 129.

As shown in FIGS. 6 and 7, the protrusive flange 114′ can have a bend140 on the anterior side of the flange, but this is not required. Thenew feature in this embodiment is that the posterior side 145 of theprotrusive flange 114′ is arcuately shaped as best shown in FIG. 8 as aconcave surface, which mates with a driver 132 having a convex surfaceshaped to match the concavity of the posterior side 145. The midpoint147, relative to being the middle or halfway point between the free end142 and the opposing end 143, of the arcuately shaped posterior side 145defines an arc of a circle having its center at the temporomandibularjoint (TMJ) in this illustration and the free end 142 has a width thatis smaller than a width of the opposing end 143 of the flange. The arcof the circle is one that defines θ₁ as being any angle with the rangeof 12 degrees to 15 degrees in increments of whole degrees, half degree,or 0.2 degree increments. The angle of the arc θ₁ defines the amount ofprotrusion of the mandible with each degree of mouth opening. The largerthis angle θ₁, the greater the protrusion with mouth opening. The largerthe angle of mouth opening, the larger the protrusion of the mandible.The arcuate surface is customizable to provide a curvature that providesthe best forward movement of the mandible for the user in relation tothe individual user's mouth shape and size. Depending upon the shape andsize of the user's mouth and jaws, the radius defining the point of thearc may be offset by moving this point up or down relative to themidpoint 147, which may change the widths of the free end 142 and theopposing end 143.

The advantage to the arcuately shaped side 145 of the protrusive flange114′ is that it will help protrude the mandible forward as theTemporo-Mandibular joint (TMJ) relaxes and the mouth falls open duringsleep, wake or any other transitional state of the human mind (such asvarious Parasomnia create) thus allowing gradual smooth arcuateincremental forward mandibular movement to occur as convex surface 145of protrusive flange 114′ smoothly glides against concave surface 136 ofdriver 132′. The maximum protrusive distance (MPD) for anterior movementof the mandible is in a range of 6 mm to 10 mm. Typically, the first 13degrees of rotation of the mandible about the TMJ during natural,un-aided spontaneous mouth opening does not move the mandibleanteriorly, i.e., this rotation does not change or open the airway.Drivers 130, 132 will actively coordinate simultaneous desired amount ofvertical and protrusive movements of the mandible (controlled bycontroller) during this first 13 degrees of mouth opening while thearcuate opposing gliding movements of convex surface 145 of protrusiveflange 114′ smoothly against concave surface 136 of driver 132′ surfaceswill passively create mild forward movement of the mandible. Driver 132will ensure constant contact between surfaces 145 and 136 while driver130 will adjust height of oral cavity and thus increase oral cavityvolume while simultaneously stiffening the soft palate and Uvula. Thisentire process will work in synergy (keeping the person's sleepundisturbed) to increase cross-sectional area of upper airway andincrease the cubic volume of the oral cavity which in turn allows 150L/R(through the controller) in 116 to appropriately incrementally protrudethe base of tongue forward into the increased oral cavity volumeutilizing electric stimulation of the tongue nerves and muscles (detailsdescribed elsewhere in this document), further increasing thecross-sectional area of the upper airway (the tongue forms the anteriorwall of the upper airway).

In the natural state, the mandible must rotate beyond this initial 13degrees, typically through another 7 to 13 degrees to have an effect onthe airway size. In an example, where the arcuately shaped side 145 isbased on a 15 degree jaw rotation (end to end) curvature, i.e., θ₁ andθ₂ are 15 degrees each or they may be any combination of two differentangles that add up to 30 degrees. The approximate midpoint 147 of thearc 145 is the point at which transition between angle of θ₂ and θ₁occurs and is approximately the point at which the mandible (mouth) isexpected to have opened or rotated to the first 13 degrees (12 to 15degree range). Total theta at the point of transition 147=180−(θ₁+θ₂).Surface 136 of driver 132 should align with the lower part of surface145 closer to 143 when the mouth is completely closed (Centric OcclusionCO with a Centric Relation CR between mandibular and maxillary incisorteeth). Angle of θ₂ can be different from angle of θ₁, i.e. the arc mayor may not be one fixed radius from TMJ. Each of the θ₁ and θ₂ shouldremain between the ranges of 12-15 degrees each although both θ₁ or θ₂or both could be zero degrees each (0-15 degrees each). These anglescould exceed 15 degrees each based on individual needs of theuser/patient. Total of (θ₁+θ₂) will ordinarily be between 24-30 degreesbut could be 0-30 degrees or greater. Theta at point of transition 147is (180−(θ₁+θ₂))=150 to 180 degrees unless angles of θ₁ and or θ₂exceeded 15 degrees. A θ of 0 degrees will essentially create a straightvertical posterior surface 145 and would require a similar angle forsurface 136. An angle of 180 would produce incremental forwardprotrusive movement of the mandible throughout the entire range ofmandibular rotation (CR/CO to MMO) during mouth opening.

θ₂ is primarily useful to control neutral mandibular protrusion duringthe initial 13 degrees of mandibular rotation (although protrusiveflange can protrude the mandible when using MRD with motorizedprotrusive flange option) but can be adjusted to produce protrusivemovement (the more θ₂ is, the less the radius of mandibular incisor toTMJ, the less protrusion of the mandible during early rotation or mouthopening and the less θ₂ is the more protrusion with each degree ofmandibular rotation). On the other hand, θ₁ is used to create themajority of the forward mandibular protrusion during the remainder ofthe mandibular rotation or mouth opening all the way to MMO (Maximummouth opening). Resistance to mouth opening will also occur during thispart of mandibular rotation due to the resistance from stretching themuscles of the TMJ as the mandible incrementally protrudes with everyadditional degree of mandibular rotation. Increasing θ₁ will cause evenmore protrusion of mandible and thus also cause incremental resistanceto mouth opening created by forward jaw movement. Essentially, if thedesired outcome is to keep the mouth closed or barely open (CR/COposition), one could use only θ₁ and remove θ₂ altogether. This wouldrequire an arcuate or non-arcuate straight posterior surface 145 with θ₁of 0-15 degrees from the vertical axis starting at base 143 all the wayup to 142 as shown in FIG. 6 and FIG. 7 with a corresponding surface 136that is straight non-arcuate surface with a corresponding angle 90+θ₁ ora corresponding arcuate surface that leans back as shown in FIG. 6 orcombination of arcuate and non-arcuate surfaces such as shown in FIG. 6.Under these circumstances, greater the θ₁ greater the protrusion of themandible with the least amount of mandibular rotation or mouth opening(mm of protrusion for each degree of mandibular rotation) and thus alsoensure the highest resistance to mandibular rotation and mouth openingto match the needs of the user/patient. In an example, where thearcuately shaped side 145 is customized with θ₁ and θ₂ of 15 degreeseach as well (total theta=180−30=150) for the sake of simplicity ofdriving home the point, a mandibular rotation or mouth opening of about20 degrees will protrude the jaw anteriorly about 5 mm and a mandibularrotation of about 24 degrees will protrude the jaw anteriorly about 11mm. Since the MPD (Maximum Protrusive Distance with range of 6-10 mm)typically has an absolute maximum of 10 mm, 11 mm is nearly impossiblefor most people and thus the mechanics of the device create theenvironment where the mouth will not open to MMO (Maximum mouth opening)of 24 degrees.

The releasably attachable features of the flange 114′ accommodates theinterchangeability of protrusive flanges 114 of different shapes andsizes to provide the best fit for the user's mouth.

Referring back to FIGS. 1 and 4, at least one stimulator 116, butpreferably both stimulators 116, include a first sensor 150L/R and/or asecond sensor 152L/R, but preferably both sensors. 150L and 152L standsfor the left side of the user and 150R and 152 R stands for the rightside of the user. The sensors 150L/R and 152L/R may be selected from avariety of sensors to create which every combination is the most likelyto be useful in diagnosing or treating the user. The sensors areselected form the group consisting of a pulse oximetry sensor, avibration sensor, an airflow sensor, a pH sensor, a combination pulseoximetry/vibration and airflow sensor, an EKG sensor, a pulse transittime (PTT) sensor, an ultrasound sensor (echocardiography), anelectro-oculogram sensor, a temperature sensor, a body position or jawposition sensor (such as a potentiometer), an electromyogram sensor, apressure measurement sensor, a hygrometer sensor, and a microphone orsound recording sensor. In one embodiment the first sensor is acombination pulse oximetry/vibration and airflow sensor and the secondsensor is a pH sensor. In another embodiment, the first sensor is apulse oximetry sensor and the second sensor is a vibration and airflowsensor. Any number of combinations of the sensors listed above ispossible and can best be selected by a medical professional based ondata relative to the pre-selected end user.

The stimulator 116 may also be accompanied by a sensor or sensors thatcan record EEG (electro-encephalogram), EOG (electro-oculogram),electromyogram (EMG) for the tongue muscles and NC (Nerve conduction)data from the nerves of the tongue, pharynx and muscles of mastication(jaw muscles) and phonation (speech). These sensors may transmit thesedata to the controller 200 (described in more detail below) throughvariety of industry standard wireless protocols that are currently inuse for wireless EMG, NC and EEG recordings in other skin surfaceapplications in neurology and sleep laboratories. Data from such sensorswill be useful for detection of various medical diseases as it will becomputed in time-synchronized manner by the controller 200 and cloudbased servers in system 300 described in more detail below and will helpto determine cause-effect of many medical diseases. The sensors willalso provide feedback to controller 200 to gauge effectiveness ofelectric stimulation of the tongue or forward movement of the tongue andmandible and thus allowing the controller to make fine adjustments toall components of the system.

The length L of each stimulator 116 will be pre-selected to fit theuser's mouth and tongue, in particular for adequate contact with thebase of the tongue during sleep. Each stimulator 116 has a single ordual electrode 154 connected to the power source 120 and generates anelectrical impulse that travels through the electrode to one or more ofthe lingual muscles of the tongue identified above, which contracts thelingual muscle(s) to create a forward movement of the tongue. Theforward movement of the tongue increases the cross-sectional open airwaydiameter in transvers, vertical and antero-posterior dimensions, thusincreasing the aggregate volume of open airway and exponentiallyreducing air-flow resistance. The power source for the single or dualelectrode can be a direct current (DC) power source or may employ anyother technology such as electro-magnetic energy, photon energy amongother forms of energy. The electrical impulses' power source will be involts or microvolts and the current, likely in milli-Amps (usually 2-6mA), will be pre-selected on a per patient basis. The power, current,and capacity will typically be within a range suitable for effectiveperformance of mated hardware and safe for use with cardiac pacemakers,defibrillators, deep brain stimulators, or spinal cord stimulators.

The forward movement of the mandible (protrusion) is performed bylateral pterygoids, medial pterygoids and masseter muscles. These arestimulated by the mandibular branch of the trigeminal nerve. Theneuronal firing rate drops during sleep relaxing these muscles causingthe jaw to fall back (retrusion) and thus allowing the tongue to fallback (retro-glossal movement) into the airway as well creating a narrowairway which is the cause of obstructive sleep apnea, oxygendesaturation, elevated blood-pressure, cardiac arrhythmia, disruption insleep and nocturnal acid reflux. The transverse stimulator 116 canspecifically target these muscle groups and their distributing nerve andstimulate and sense electrical activity of these various musclesindividually or together inside the oral cavity.

Also, the stimulators 116 can stimulate selected muscles to improvetheir strength. This can be a training or a retraining exercise, forexample, after a stroke (swallowing difficulty or speech difficulty) orfor children with speech pathologies. If sensors are present in thestimulators 116, the sensors can provide data to the controller station200 and the system 300 of FIG. 11 to determine which muscle and/ormuscle group needs attention. Thus, the shape of exteriorsurface/housing of the stimulators 116 are shaped and sized to directeach and every sensor, stimulator or combination thereof to theappropriate location inside the oral cavity.

The pulse oximetry sensor 150 is positioned in one or both stimulators116 at a position enabling direct contact with the base of the tonguefrom which data will be collected. The position of the pulse oximetrysensor 150 is generally antero-superiorly positioned for measuringpulse-oximetry through the blood-flow of the tongue. The vibration andairflow sensor 152 is positioned in one or both stimulators 116 at aposition suitable for airflow measurements, which can indicate whenthere is a restriction of airflow, and vibration measurements (sub-sonicand sonic) that are an indication of inaudible and audible snores. Thevibration and airflow sensor 152 faces posteriorly to measure snores andairflow resistance/pressure from the airway.

The power source 120, 121 in all embodiments may be a rechargeablebattery. In one embodiment, the rechargeable battery is one or moremicro-lithium ion batteries in each housing 108, 109. Solar/lightcharging energy source that can be recharged by ambient lighting (usedin the watch maker industry) or solar power may also be considered for arechargeable source of energy. The rechargeable battery may have amaximum discharge milli-amperage creating a mechanical mandibularprotrusion or retrusion ranging between 1-10 mm in linear dimensions forthe movement of the drivers 130, 132.

As seen in FIGS. 1 and 2, each housing 108, 109 of the mandibular andmaxillary pieces, respectfully, include a charging member 118, 119, suchas a charging plate, in an exterior surface thereof. In the figures, thecharging plate is in a lateral side of the housing 108, 109, but is notlimited thereto.

As best seen in FIG. 3, the first driver 130 may be a flat plateconnected to the motor 122 by the linkages 134.

The motor 122, 123 in all embodiments may be a single or dualpiezoelectric motor having a linearly movable linkage(s). Micro motorsbased on piezo electric materials are commercially available from PiezoMotor, a company headquartered in Sweden and may be modified as neededfor use in the disclosed devices. The motor 122, 123 may include aposition sensor.

As best seen in FIGS. 3 and 6, the maxillary piece 102 sits on themandibular piece 104 with the first driver 130 operatively engaged withthe maxillary piece 102 and the second driver 132 operatively engagedwith the protrusive flange 114, 114′, or 114″ of the mandibular piece104. Each of the drivers 130, 132 can move the jaws in increments of 0.1mm up to 2 mm with each movement with a maximum of 12 mm in therespective direction. The protrusive flange 114, 114′, 114″, is moveableby the second driver 132 in a range from 0.1 mm to 11 mm and the firstdriver 130 can lift the maxillary portion in a range from 0.1 mm to 12mm.

Referring again to FIG. 6, the second driver 132 has a head 136 that isshaped to fit the shape of the posterior side 145 of the protrusiveflange 114′. The head 136 has a convexly-shaped anterior side to pressagainst the posterior side 145 of the protrusive flange 114′.

Turning now to FIG. 8, a mandibular device 101 is illustrated that hasjust the stimulator 116 and a mandibular teeth covering 105. As such,the maxillary piece can comprise of a teeth covering 107 as shown inFIG. 2 without the housings 109 or be absent, i.e., the user can justhave the mandibular device 101 in their mouth during use. Dual housings108′ are present with one each proximate a left molar portion 110 and aright molar portion 112. A stimulator 116 extends from each housing 108′toward the tongue at a position to lie under the tongue in contact withlingual muscles, in particular the Genioglossus (GG), the Geniohyoid(GH), sub-mentalis (SM), and Glossopharyngeal (GP). Each housing 108′includes a charging feature 118 for recharging any battery(ies) housedtherein, as described above.

Referring now to the cross-section of FIG. 10 through one of thestimulators 116, each stimulator 116 houses therein, in a fluid-tightmanner, a first sensor 150, a second sensor 152, and a stimulatorelectrode 154. In FIG. 10, the first sensor 150, the second sensor 152,and the stimulator electrode 154 are each electrically connected to thepower source 120 within housing 108′. The electrical connections may bedirect connections to the power source 120, which may be accomplished bya plug-n-play electrical connector 156, or, as represented by the dashedlines, may be accomplished by a plug-in style connector 157 to themicroprocessor 159 and thereby to the power source.

In one embodiment, the first sensor 150 is a pulse oxygen sensorcontinually measuring oxygen data at the base of the tongue and thesecond sensor 152 is a vibration/air flow sensor measuring snoring,turbulent flow, and vibrations from inside the user's mouth. As notedabove with respect to FIG. 4, multiple other sensors and sensorcombinations are possible that will provide data to the microprocessor159. The circuit board 124 within the housing 108′ is in operativeconnection to the power source to be powered and to control activationof the stimulator electrode 154 in response to data received by thecircuit board 124, more particularly, the microprocessor 159, from thefirst sensor 150 and/or the second sensor 152. As discussed themicroprocessor 159 receives the sensor data, processes the sensor data,and determines whether the stimulator electrode 154 needs activated.

Each of the stimulators 116 may include a pH electrode too. The pHelectrode will measure the acidity at the back of the tongue, which iftoo high is an indication of chronic high acid reflux.

Referring now to the FIG. 11, which is a transverse cross-sectionthrough one of the stimulator/sensor protrusions 117 and housings 108′of a mandibular device similar to the mandibular device 101 of FIG. 9.In this embodiment, each housing 108′ and stimulator/sensor protrusion117, rather than being built as part of the teeth covering 160, areremovably attachable to the teeth covering 160. Each housing 108′defines a groove 162 shaped to receive therein an end 161 of the teethcovering 160, such that one housing 108′ is removably attached to afirst end 161 defining a left molar portion and the other housing108′(not shown) is removably attached to a second end (not shown) of theteeth covering 160 defining a right molar potion thereof. The groove 162may have opposing flanges 164 positioned at and parallel with a bottomsurface 166 of its housing 108′ and extending toward the open voiddefined by the groove 162. The groove 162 of each housing 108′ may beslid over and be received on the teeth covering, may have a snap fit tothe teeth covering, may have an interference fit, or may be fabricatedin two parts that can snap into each other over a predetermined locationof the teeth covering or may be fabricated with three-dimensionalprinting over a teeth covering. The illustrated embodiment in FIG. 11has the housing 108′ slidingly received on the first end 161 of theteeth covering 160 with the flanges 164 resting against bottom surfacesof each of the sides of the teeth covering 160. Regardless of the typeof attachment, each housing 108′ is movable fore and aft to adjust theposition of the stimulator/sensor portion under the correct positionunder the tongue of the user.

Since the housings 108′ are removably attachable to the teeth covering160, each housing and or teeth covering may be disposable or reusable.When the housings 108′ are reusable, the housings are constructed of amaterial suitable for sterilization between uses, such as by autoclavesterilization. Housed within each housing 108′, in a fluid-tight manner,is a first sensor 150, and an optional second sensor 152, and anoptional third sensor 153 or a stimulator electrode 154 or even ahigh-pressure pellet discharge system. Each of the first sensor 150, thesecond sensor 152, and the third sensor 153 or the stimulator electrode154 are electrically connected to the power source 120. The electricalconnections may be direct connections to the power source 120, which maybe accomplished by a plug-n-play electrical connector 156, or may beaccomplished by a plug-in style connector to the microprocessor 159 andthereby to the power source 120. The housings 108′ each include acharging member 118 in an exterior surface thereof for coordination withone of the charging units 202, 204 of the controller station 200 of FIG.5.

In one embodiment, only the first sensor 150 is present. The firstsensor 150 may be, but is not limited to, a pulse oxygen sensor, avibration and airflow sensor, a pH sensor, a doppler ultrasound, anM-Mode ultrasound, a 2D ultrasound, 3D ultrasound, a pressure plate formeasuring bruxism, a pulse transit time sensor, non-invasive ventilationsystolic/diastolic blood pressure sensor, a carotid doppler (trans-oral)sensor, or a cardiac trans-oral echocardiography sensor or acamera/videography system. In one embodiment, the first sensor 150 is apH sensor. In another embodiment, the first sensor 150 is a pulse oxygensensor continually measuring oxygen data. The mandibular device 101 isused with the controller station 200 in a diagnostic mode.

Since there are two housings 108′ each having a stimulator/sensorprotrusion 117, each housing 108′ may have a different type of sensorfor the first sensor 150 or one may have a first sensor 150 and theother may have the stimulator 154. As such, the mandibular device 101can be used in a diagnostic mode or a treatment mode depending upon theselection of sensors and/or stimulator in the housings 108′, therebyproviding great versatility in use. Furthermore, since the housings 108′are removable attachable to the teeth covering 160, the housings 108′can be switched for housings having different sensors in a sequence ofnights to assess various parameters of the user or during the day orboth night and day. The mandibular or maxillary housings or teethcoverings, when used alone (mandibular or maxillary) should allow mostspeech functions and thus can be used during the course of a normal day.The data interfaces with standard Bluetooth functionality or WIFIfunctionality and the controller station may be used as a mobile unitwith Bluetooth and WIFI functionality and as such may be carried to workor elsewhere since it has its own rechargeable battery operations.Controller station will be interfaced with proprietary or open platformprogram that can be securely loaded on variety of computer systems andhand-held smart devices.

In another embodiment, the first sensor 150 in a first of the housings108′ is a pulse oxygen sensor continually measuring oxygen data at thebase of the tongue and the second sensor 152 is a vibration/air flowsensor measuring snoring, turbulent flow, and vibrations from inside theuser's mouth; the second of the housings 108′ has a pH sensor as thefirst sensor and includes the stimulator 154. Here, diagnostic andtreatment functions are possible that are coordinated by the system 300or any of its components such as controller or PC or smart device. Thesensors 150, 152 provide data to the microprocessor 159. The circuitboard 124 within the housing 108′ is in operative connection to thepower source to be powered and to control activation of the stimulatorelectrode 154 in response to data received by the circuit board 124,more particularly, the microprocessor 159, from the first sensor 150and/or the second sensor 152 and/or from instructions from thecontroller station 200 and/or the cloud server as shown in FIG. 12(described in more detail below) to effect a treatment. For example, ifthe pH sensor senses an increasing acid condition as the user sleeps andthe other sensors measure airflow resistance or decreased airflow, thenthe stimulator will be activated to open the airway and the system willthen determine if the pH decreases. Such a causal relationship may helpreduce/prevent significant nocturnal acid reflux and thus minimize oreliminate the use of acid reflux medications. Moreover, the combinationof sensors can be selected to determine time synchronization of the pHto other physiological occurrences of the user, such as body position,inspiration, expiration, sleep measurements, oxygenation, bruxism,snoring, apnea, etc. Ideally, a link between acid reflux and otherphysiological occurrences can be determined and then used for treatment.

Moreover, using the controller station 200 and cloud server of thesystem 300, it will be possible to receive data regarding the user'sinput of food and time consumed to act proactively during sleep based ona correlation of digestion time and acid reflux onset. This capabilitymay be extended to input of any and all medications, physiological datasuch as BP, EKG and blood sugar, and to administering of any and allmedications during the day (prompted to the user through hand helddevice) or night (automatically performed if pressure pellet formedication is available to the system to discharge sub-lingually inliquid form or inhaled as micro-aerosol powder form.

The teeth covering 160 in the embodiment of FIG. 11 can be as simple asa plastic boil and bite mandibular device onto which the housings 108′are removably attachable. In this manner, the teeth covering 160 isdisposable and are readily available. Other teeth coverings 160 arecommercially available that are generally cheap and disposable such asora-guard, sonabul, oral-b etc. However, the teeth covering 160 is notrequired to be disposable. Instead, the teeth covering 160 can beconstructed of a material that is sterilizable such that the teethcovering is reusable by a user or users over a preselected time periodwhile sterilizing the housings 108′ and utilizing any combination ofhousings 108′ having a variety of sensors to monitor as manyphysiological parameters of the user as selected by administeringexpert.

Turning now to FIGS. 5 and 12, a controller station 200 is illustratedfor operatively controlling any of the mandibular lingual repositioningdevices 100, 101 described above, which together define a system 300schematically illustrated in FIG. 12. The controller station 200 has ahousing 201 defining a first charging unit 202 for receipt of themaxillary piece 102 and a second charging unit 204 for receipt of themandibular piece 104. The first and second charging units 202, 204 maybe receptacles defined in a surface of the housing 201. In anotherembodiment, the first and second charging units 202, 204 may begenerally flat plates. The housing 201 has a display screen 203 fordisplaying information to a user and one or more ports 206 forconnecting the charging station to power, other devices, and/or theinternet. Alternately, instead of ports 206, the housing 201 can enclosewireless communication technology for other devices 310, for example,but not limited thereto, a printer, speakers, tablets, laptops, cellularphones, smart watches, and other cloud-based devices. The controllerstation 200 may include sensors to record ambient room conditions, suchas light, temperature, humidity, noise/sound, etc. The controllerstation 200 optionally is battery powered and may include a rechargeablebattery. The controller station 200 may be portable.

Alternately, rather than having the first and second charging units 202,204 integrated into the controlling station 200, a separate chargingstation (not shown) having a first and second charging unit is possible.The charging station may be portable.

When the charging station is separate from the controller station 200,the controller station may be incorporated into a hand-held smart deviceand such a smart device would share blue tooth, WIFI, Video, audio andcommunication capability with sensors. In one embodiment, the controllercan be a proprietary software program for use with or an App (softwareapplication) having full functionality to function like the controllerstation 200. System 300 and controller station 200 in all itsembodiments will be HIPPA and HITECH compliant for purpose of medicalprivacy. Interface with the wide variety of electronic health formats(EHR) would allow system 300 and controller station 200 and its operatedsystems to be available for real-time data download and upload, activehealth care worker involvement in user's health care needs and wouldpermit the health care worker to operate and alter any treatment andaccess and interpret diagnostic information provided by the system. Assuch controller station 200 and system 300 would allow newer formats ofhealth care provisions such as tele-medicine and others yet to bedefined. System 300 may be integrated into a full-function health caresoftware-hardware system for patient assessments (such as telemedicine),tests, treatments and medications.

The controller station 200 encloses a circuit board having amicroprocessor, including memory (non-transitory computer readablemedia) in which is stored firmware and learning algorithms, having areceiver of electronic communications, and having a transmitter ofelectronic communications, including wireless communication capabilitiesto electronically communicate with at least the MLRD 100, 101 forreal-time communications with the sensors on board the MLRD. The MLRD100, 101 has microprocessors on-board with a transmitter to transmit rawdata from all sensors, stimulators and pressure pellets exemplified bythe pulse oximetry sensor, the vibration and airflow sensor, lingualstimulator, lateral pterygoid stimulator, medial pterygoid or masseterstimulator, EKG sensor, sub-lingual nitroglycerine pellet discharge,etc. to the controller station 200 in real-time aided by system 300 forprocessing into executional commands exemplified by movements of thefirst driver and/or the second driver and activation of the stimulatorfor tandem or synchronized movements and activation thereof, i.e.,simultaneous, independent, or sequential activation of the motors andthe stimulator, training of muscles of speech or swallowing includingthe sequence of movement and strength and duration of current or releaseof a medication for sublingual or aerosolized use. The controllerstation 200 can simultaneously transmits the instructions to the MLRD100, 101 microprocessors in each housing 108, 109, 108′ which implementthe instructions, exemplified by synchronizing the cranial to caudaladjustments, the anterior to posterior adjustments, and activation ofthe stimulator etc. The MLRD may also operate as a stand-alonemandibular protrusive and vertical advancement device or as astand-alone lingual/pterygoid stimulator device or a timed-medicationrelease device as preferred by treating health care provider.

The circuit board of the controller station 200 receives data from thepulse oximetry sensor and/or the vibration and air sensor and activatesthe motors and the stimulator as needed after a pre-selected number ofbreaths of the user. The firmware and algorithms, including learningalgorithms as well as standard algorithms, stored in the memory of thecircuit board may define the pre-selected number of breaths to be everybreath, every other breath, every five breaths, or an absence ofbreath(s). Since the movements of the MLRD 100, 101 are done inreal-time, the airway of the user can be opened without disturbing thesleep of the user.

The controller station 200 has a microprocessor configured to processthe data and instruct the MLRD 100, 101. However, the controller station200 can communication with a server, such as a cloud server, for furtherprocessing if desired, or for additional memory storage and/orcommunication of the data to authorized healthcare providers and/orsleep analysis experts, etc. and/or communicate with a database of saidperson. This intercommunication of databases can create therapeuticinterventions and diagnostic testing of a user while at home. Thissystem 300 enables an authorized healthcare provider to monitor andrecord patient data in real time, learn the patient, and alter thepatient's treatment in real-time. The communications to and from theserver can be through a wired or a wireless connection.

The server can also send commands, configuration data, software updates,and the like to the controller station 200. The configuration data mayinclude, but is not limited to, configuration parameters for the system300, configuration parameters for a particular user, and/ornotifications, feedback, instructions, or alerts for the user.

The system 300, in addition to the MLRD 100, 101 can wirelesslycommunicate with additional sensors connected to the user to provide abroader data set for a more complete picture of the user's physiology.For example, electrocardiogram (EKG), electromyography (EMG),electrooculography (EOG), electroencephalography (EEG) sensors,echocardiography, blood pressure monitoring systems, and sensors sensingenvironmental conditions, such as temperature, ambient light, andhumidity. The system may include a camera for video recording throughthe controller station 200 to evidence any nocturnal seizures,sleep-walking, other movement or violent disorders during sleep.

In operation, data from the sensors on the MLRD 100, 101, such as oxygenmeasurements and pulse data, is sent to the controller station 200 to beprocessed by the microprocessor to determine how much movement of theprotrusive flange by activation of the second driver is needed, how muchmovement of the first driver is needed to separate the jaws of the user,and if and when to stimulate the transverse lingual muscle of the tongueto move the tongue forward. After some breaths, the controller station200 may determine to stimulate the tongue and activate the second driverto move the mandibular piece, and hence the jaw of the user, forward(anterior) or backward (posterior) direction. In other instances, thecontroller station 200 may determine to stimulate the tongue andactivate both the first driver and the second driver to separate thejaws and move the mandibular piece forward in order to adequately openthe airway of the user.

The system 300 also creates three-dimensional images and videos ofbreathing, cardiac function, carotid blood flow data, eye-movements, jawmovements and brain EEG recordings for identification of medicalconditions and interventions that may be useful to correct or treatthose medical conditions.

A unique advantage of this system over any other existing systems isthat the jaw and tongue can move synchronously, independently, orsequentially during sleep in real-time and in anticipation of impendingairway closure and in a provision of a measured response to restrictionof airflow as determined by the controller station 200 even before theairway has completely closed; thus, restoring unrestricted airflow evenbefore the patient has completely stopped breathing. This system can seeairway obstruction before it happens and will keep the airway constantlyopen in any body position or depth of sleep. This is a distinctadvantage over CPAP/BIPAP or any other mechanical or electrical systemthat is commercially available in the market. In addition, there aredistinct advantages just by the breadth of functionality that has beendescribed above.

The controller station 200 includes learning algorithms in the memory ofthe microprocessor that learns a user's sleep patterns and otherphysiological events and functions during sleep and wake, pathologicalevents and activities during wake and sleep from the data collected overtime and creates a “best response” for the simultaneous, independent, orsequential responses exemplified by tensing of the soft palate or Uvula,release of medication or stimulation of the stimulator and activation ofthe first and second drivers to open the airway or to train muscles ofspeech, and to synchronize these best responses such as exemplified bycertain jaw movements that are associated with particular phases ofrespiration. The activation of the first and second drivers 130, 132 notonly includes advancements, but also retractions of the first and seconddrivers 130, 132 to relax the jaws in between necessary advancements toopen the airway to avoid potential TMJ problems. Any discussions hereindirected to the mandibular component, with respect to the controllerstation 200 and the system 300, are equally applicable to the maxillarycomponent.

The controller station 200, in the memory of the microprocessor, mayinclude a pre-programmed range for the movements of the first and seconddrivers 130, 132 based on sleep study data for the user conducted by anauthorized healthcare provider. The pre-programmed range can be used bythe controller station 200 in a stand-alone or auto servo mode. Thepre-programmed range may be determined by simple or multiple linearregression models that employ data from inputs and from previousexperiences, which the controller station 200 will be able to forecastranges for the amount and direction of movements of the drivers 132, 134and the amount or timing of energy discharge through the transversestimulator(s). The controller station 200, in the memory of themicroprocessor, may include data from tests previously performed on theuser and/or the output of algorithms to set the MLRD 100, 101 each dayfor use just prior to sleep.

The controller station 200 can operate based on a standalone function ora servo function. In the standalone function, the controller station 200operates the MLDR 100, 101 based on set parameters for the movement ofthe drivers, such as repetitive equal advancement and retraction of themandible that are not based on active feedback. For example, a set 2 mmmovement anteriorly of the mandible during each breath and a 2 mmposterior movement of the mandible after each breath, with a fixedamount of energy discharge to the electrode of the stimulator. The setparameters for the standalone function may be based on data collectedfrom the specific user or may be based on a peer group of like sleepattributes.

In the servo function, the controller station 200 interactively controlsthe MLRD 100, 101 during sleep or wake, at home or elsewhere, based onthe data collected from the sensors on-board the MLRD in a feedback loopand based on data available from the server. During operation, thecontinual feedback loop allows incrementally accurate interventionsfollowed by listening to observational inputs exemplified by airflowmeasurements, video recordings, pulse-oximetry, doppler flow in carotidsor advancement of mandible and followed by more interventionsexemplified by protrusive or vertical adjustments based on real-timedata even after a previous advancement or incremental increase in energyto stimulate the tongue. The changes to the advancement or applicationof energy to the stimulator will be capable of producing positive andnegative changes regarding movement of the mandible and tongue. Forexample, the energy applied to the stimulator may be reduced relative tothe prior application of energy discharge if the previous discharge ofenergy caused teeth grinding or cough. In another example, theprotrusive movement of the jaw may be reversed if the previousprotrusion advancement caused a deleterious change in any of themonitored physiological parameters. In another example training ofmuscles of swallowing would be altered upon observing retrogrademovement of food or appearance of cough or gag.

Also, in the servo function, data from all sources, server, MLRD, andany other sensors attached to the user that are communicating with thecontroller station 200, are continuously processed through algorithmsthat are stored in the memory of the controller or stored in the server.Examples of other sensors includes, but is not limited to, wirelesspulse-transit time sensors, and wireless EKG sensor. These twoadditional sensors would be utilized in addition to the MLRD to diagnoseand treat sleep-induced hypertension and/or cardiac arrhythmia such aslack of oxygen to the heart, especially by collecting time synchronizeddata from the EKG sensor and the pulse oximeter sensor. For example, theserver may include data related to sleep attributes and alcoholconsumption to make adjustments for the user during sleep after drinkingalcohol. For example, it may require a change in current applied to thestimulators 116 after alcohol consumption to effectively stimulate thelingual muscles. The same may be true of a user taking certainmedications, especially those that depress brain function. As anotherexample, the server may include data on myriad patients correlatingsleep attributes to weight loss. As such, if the user loses 5 or 10pounds, data from the server can be considered in the algorithmdetermining how much movement of the jaws is needed and/or whether tostimulate the tongue.

The system 300 may be used to treat many medical diseases, including butnot limited to any type of sleep apnea, bruxism, sleep related GERD,sleep-induced hypertension, snoring, etc.

The system 300 may be used to diagnose any possible medical conditionsrelated to sleep or while awake, including sleep apnea or other sleepdisorders including sleep-induced hypertension, sleep-related cardiacarrhythmia, sleep related seizures, RLS and periodic limb movementdisorders and other medical diseases, even those unrelated to sleep.Here, the MLRD 100 or 101 is placed in the user's mouth during a sleepperiod, such as at night, with the controller station 200 in a “testmode” in which the on-board sensors measure and monitor the user'sphysiological parameters mentioned above. The test mode is used formultiple sleep periods of over two to 30 days, based on a time periodset by a medical professional. For example, the user may have thecontroller station in “test mode” for seven days. Then, the seven daysof data is reviewed by the medical professional to determine whether theuser has sleep apnea or any other sleep disorder, and if so, determinesthe parameters for the standalone mode, which are then stored in thecontroller station 200. The same system may be used even during the dayand outside of the home of the user such as at place of work.

The system 300 may have a therapeutic mode, which implements the servofunction. Here, the feedback loop is on for data from the on-boardsensors, which is processed through an algorithm to determine the leastamount of anterior and caudal movement to maintain an open airway andthe least amount of energy discharge to stimulate the tongue andmaintain an open airway and the order in which to take such actions,i.e., simultaneously, sequentially, or individually.

The device and system disclosed herein have numerous advantages,including artificial intelligence utilizing data collected by the MLRDduring use to actively in real-time adjust the MLRD in response to thephases of respiration, degree of obstruction of the airway, snore soundsand vibrations and amount of hypoxemia present relative to each breathirrespective of the stage of sleep of the user. The system is capable ofmeasuring a large number of cardiac, neurological and endocrine sensoryinputs as described above exemplified by continuous non-invasiveglucose, oxygen, blood pressure, pH monitoring, heart rhythm andtemperature etc. The system is capable of photography for creatingdental impressions, dentures or to diagnose gum disease etc. The systemis capable of executing a large spectrum of functions such as mandibleprotrusion, administering sub-lingual insomnia medication likeIntermezzio or cardiac medication like Nitroglycerine or training musclegroups for swallowing or speech. The system is capable of communicatingwith user, provider, EHR (Electronic Health Record) and pharmacy etc.This system is capable of determining restriction to airflow, increasein velocity of air and turbulence, decreasing levels of oxygen andincreasing levels of heart rate, pH monitoring and any otherphysiological parameter that could be installed in the future withconstant inputs of physiological parameters (unlike with CPAP machine ororal appliances that are available in the industry), such as thosementioned above. This collection and processing of data allows thesystem to actually make adjustments exemplified by the movement of themandible and tongue prior to closure of the airway and hence will workas a preventative form of treatment for sleep apnea.

Age and gender specific physiology of the airway and the mouth duringsleep are known to affect sleep and cause sleep disorders. The system300 and 310 will collect data that will enable the development ofalgorithms that are age and gender specific, which can improve treatmentoutcomes for future users. System 300 and 310 has ability to createdatabase of all physiological and pathological events measured inreal-time and time synchronized with each other in its users and developalgorithms for normal and abnormal manifestations of disease statesduring wake and sleep and develop new cause-and-effect understanding ofthese events that have never been observed before. Recording andcorrelation of these phenomenon with sensors, especially during sleepwould help understand conditions such as ‘wake-up strokes’ (occur duringsleep) that account for 14% of all strokes and diagnose conditions likeobstructive sleep apnea that occurs with almost 83% of cardiovasculardisease, 58% of heart failure and 53% of atrial fibrillation, to name afew.

The system not only advances movement of the mandible (cranially andanteriorly), but enables a relaxed movement of the mandible (caudallyand posteriorly), which allows the temporomandibular joint to relaxperiodically to prevent jaw discomfort, temporomandibular joint strainand destabilization, morning stiffness of said joint, and alteration ofthe user's bite.

The system 300 can also be used for users that snore, but who do not yethave sleep apnea. The inclusion of the vibration and airflow sensorenables the measurement of the intensity of snoring and can open theairway before the sub-sonic snore has become audible. The inclusion ofstimulators of soft palate and uvula can reduce or eliminate snoring inusers that do not have sleep apnea yet. Also, the system 300 can be usedalong with a CPAP machine and enable the CPAP machine to be used at alower air pressure than a typical setting for user's that cannottolerate CPAP machine at their typical air pressure.

It should be noted that the embodiments are not limited in theirapplication or use to the details of construction and arrangement ofparts and steps illustrated in the drawings and description. Features ofthe illustrative embodiments, constructions, and variants may beimplemented or incorporated in other embodiments, constructions,variants, and modifications, and may be practiced or carried out invarious ways. Furthermore, unless otherwise indicated, the terms andexpressions employed herein have been chosen for the purpose ofdescribing the illustrative embodiments of the present invention for theconvenience of the reader and are not for the purpose of limiting theinvention.

Having described the invention in detail and by reference to preferredembodiments thereof, it will be apparent that modifications andvariations are possible without departing from the scope of theinvention which is defined in the appended claims.

What is claimed is:
 1. A lingual repositioning device comprising: amandibular piece having a teeth covering having a left molar portionand/or a right molar portion and a first housing proximate at least oneof the left molar portion or the right molar portion; wherein the firsthousing includes a stimulator protrusion extending therefrom at aposition to extend toward a tongue of a user and to contact a lingualmuscle of the tongue; wherein the stimulator protrusion encloses astimulator, and the first housing encloses a power source electricallyconnected to an on-board circuit board and electrically connected to anelectrode of the stimulator.
 2. The lingual repositioning device asclaimed in claim 1, wherein the power source is a rechargeable batteryand the first housing has a charging member in an exterior surfacethereof that is in electrical communication with the rechargeablebattery.
 3. The lingual repositioning device as claimed in claim 1,wherein the on-board circuit board includes a receiver, a transmitter,and a microprocessor having instructions to activate the stimulator. 4.The lingual repositioning device as claimed in claim 3, wherein thestimulator protrusion encloses one or more sensors in communication withthe microprocessor of the on-board circuit board.
 5. The lingualrepositioning device as claimed in claim 4, wherein the one or moresensors are selected from the group consisting of a pulse oxygen sensor,a vibration and airflow sensor, a pH sensor, a doppler ultrasoundsensor, an M-Mode ultrasound sensor, a 2D ultrasound sensor, 3Dultrasound sensor, a pressure plate sensor for measuring bruxism, apulse transit time sensor, non-invasive ventilation systolic/diastolicblood pressure sensor, a carotid doppler (trans-oral) sensor, and acardiac trans-oral echocardiography sensor.
 6. The lingual repositioningdevice as claimed in claim 3, wherein a first sensor of the one or moresensors is a pulse oximetry sensor and a second sensor of the one ormore sensors is a vibration and airflow sensor.
 7. The lingualrepositioning device as claimed in claim 4, wherein the on-board circuitboard receives data from the one or more sensors and activates thestimulator in the first housing as needed based on the data to open anairway of a user.
 8. The lingual repositioning device as claimed inclaim 1, comprising a second housing proximate the other of the leftmolar portion or the right molar portion; wherein the second housing hasa stimulator protrusion extending therefrom at a position to extendtoward a tongue of a user and to contact a lingual muscle of the tongue;wherein the stimulator protrusion encloses a stimulator, and the secondhousing encloses a power source electrically connected to an on-boardcircuit board and electrically connected to an electrode of thestimulator.
 9. The lingual repositioning device as claimed in claim 8,wherein the stimulator protrusion of the second housing encloses a firstsensor and/or a second sensor in communication with the microprocessorof the on-board circuit board.
 10. The lingual repositioning device asclaimed in claim 10, wherein the first sensor and/or the second sensorof the second housing are selected from the group consisting of a pulseoxygen sensor, a vibration and airflow sensor, a pH sensor, a dopplerultrasound sensor, an M-Mode ultrasound sensor, a 2D ultrasound sensor,3D ultrasound sensor, a pressure plate sensor for measuring bruxism, apulse transit time sensor, non-invasive ventilation systolic/diastolicblood pressure sensor, a carotid doppler (trans-oral) sensor, or acardiac trans-oral echocardiography sensor.
 11. The lingualrepositioning device as claimed in claim 8, wherein the first sensor andthe second sensor of the second housing are different from one anotherand are different from the one or more sensors of the first housing. 12.The lingual repositioning device as claimed in claim 8, wherein theon-board circuit board of the second housing includes a receiver, atransmitter, and a microprocessor having instructions to activate thestimulator in the second housing.
 13. The lingual repositioning deviceas claimed in claim 12, wherein the on-board circuit board of the secondhousing receives data from the first sensor and/or the second sensor andactivates the stimulator in the second housing as needed based on thedata from the first sensor and/or the second sensor to open an airway ofa user.
 14. The lingual repositioning device as claimed in claim 1,wherein the first housing is removable attachable to the teeth covering.15. The lingual repositioning device as claimed in claim 14, wherein theteeth covering is a bite and mold disposable plastic teeth covering. 16.The lingual repositioning device as claimed in claim 14, wherein thefirst housing is slidably received on the teeth covering, or has a snapfit to the teeth covering.
 17. A mandibular lingual repositioning systemcomprising: a mandibular piece having a teeth covering having a leftmolar portion and/or a right molar portion and a first housing proximateat least one of the left molar portion or the right molar portion;wherein the first housing includes a stimulator protrusion extendingtherefrom at a position to extend toward a tongue of a user and tocontact a lingual muscle of the tongue; wherein the stimulatorprotrusion encloses a stimulator and a first sensor, and the firsthousing encloses a power source electrically connected to an on-boardcircuit board and electrically connected to an electrode of thestimulator; and wherein the on-board circuit board includes a receiver,a transmitter, and a microprocessor; and a controller station inwireless communication with the mandibular lingual repositioning devicewhile used by a user, the controller station comprising: a circuit boardcomprising a microprocessor, a receiver, and a transmitter, wherein themicroprocessor comprises non-transitory memory having firmware andlearning algorithms stored therein; wherein the receiver receives datafrom the first sensor, while used by the user, and the microprocessor ofthe controller station processes the data and transmits stimulatoractivation instructions to the microprocessor of the on-board circuitboard.
 18. The system as claimed in claim 17, wherein the receiver andtransmitter of the controller station communicate with a database of aphysician, the Internet, a personal electronic communication device andcombinations thereof.
 19. The system as claimed in claim 17, wherein thecontroller station includes input and output ports for electricalinterconnection to a power source and/or other electronic devices. 20.The system as claimed in claim 17, wherein the controller stationcomprises a first charging unit for the mandibular piece and a secondcharging unit for the maxillary piece.